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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03416088
Other study ID # YFZX2017001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date December 31, 2020

Study information

Verified date February 2022
Source Shanghai Eye Disease Prevention and Treatment Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The daily behaviors such as drinking coffee, wine, reading, exercise and body postural changes may have influence on the function or morphology of the retinal microcirculation in healthy people.A recent study found that the fingertips microvascular bed constricted obviously after the intake of a cup of coffee with caffeine, it significantly reduced blood flow to the fingers; Long reading of electronic products can induce significant dry eye symptoms, affect visual quality, and cause asthenopia. Microcirculation is critical for regulating vascular resistance and blood flow in organs. Fundus blood vessels is the only visible microvascular in vivo, its morphology and function changes not only associated with eye disease, but also with cardiovascular and cerebrovascular diseases. Optical coherence tomography angiography (OCTA) is a new technique which could acquire blood flow information in a non-invasive way without the use of dye. Magnetic resonance imaging (MRI) can quantitatively evaluation of cerebral blood flow and retina-choroid blood flow using the noninvasive arterial spin labeling technique in a large field of view (FOV) without depth limitations.The study tried to detect the influence of daily behaviors such as drinking coffee, red wine, reading ,and exercise on the retinal microcirculation with OCTA and MRI, and provide reference for health behaviors.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date December 31, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria 1. Healthy adults 2. The age range was from 18 to 25 years old 3. Without another eye disease besides ametropia 4. The spherical equivalent is equal or above minus 3.00 diopters 5. No smoking or drinking 6. Average daily caffeine consumption no more than 1 cup of coffee 7. No diabetes, hypertension, heart disease, liver or kidney dysfunction 8. No medication taken recently Exclusion Criteria 1. Mental disorders such as depression and anxiety 2. Intellectual disabilities 3. Female in menstruation, gestation period, perinatal period or lactation period 4. Unable to cooperate with eye examinations and test procedures 5. Heart disease, hypertension, diabetes, liver and kidney dysfunction and other chronic diseases 6. Patients with fever, acute infectious diseases 7. Other conditions that are not suitable for drinking alcohol or coffee, such as allergic to alcohol or coffee

Study Design


Related Conditions & MeSH terms

  • Retinal Microcirculation Disorder

Intervention

Behavioral:
Beverage consumption
The participants drink 300ml wine (alcohol concentration:12.5%)or 300ml coffee (caffeine concentration 72 mg), or water.
Daily reading
Reading paper books, playing video games with mobile phones, or non-reading for 8 hours.
Body motion
Exercise or body postural changes

Locations

Country Name City State
China Shanghai Eye Disease Prevention & Treatment Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Jiannan Huang

Country where clinical trial is conducted

China, 

References & Publications (8)

Karti O, Zengin MO, Kerci SG, Ayhan Z, Kusbeci T. ACUTE EFFECT OF CAFFEINE ON MACULAR MICROCIRCULATION IN HEALTHY SUBJECTS: An Optical Coherence Tomography Angiography Study. Retina. 2019 May;39(5):964-971. doi: 10.1097/IAE.0000000000002058. — View Citation

Kojima S, Sugiyama T, Kojima M, Azuma I I, Ito S. Effect of the consumption of ethanol on the microcirculation of the human optic nerve head in the acute phase. Jpn J Ophthalmol. 2000 May;44(3):318-9. — View Citation

Lawrenson JG, Hull CC, Downie LE. The effect of blue-light blocking spectacle lenses on visual performance, macular health and the sleep-wake cycle: a systematic review of the literature. Ophthalmic Physiol Opt. 2017 Nov;37(6):644-654. doi: 10.1111/opo.12406. Review. — View Citation

Luksch A, Resch H, Weigert G, Sacu S, Schmetterer L, Garhöfer G. Acute effects of intravenously administered ethanol on retinal vessel diameters and flicker induced vasodilatation in healthy volunteers. Microvasc Res. 2009 Sep;78(2):224-9. doi: 10.1016/j. — View Citation

Malerba S, Turati F, Galeone C, Pelucchi C, Verga F, La Vecchia C, Tavani A. A meta-analysis of prospective studies of coffee consumption and mortality for all causes, cancers and cardiovascular diseases. Eur J Epidemiol. 2013 Jul;28(7):527-39. doi: 10.1007/s10654-013-9834-7. Epub 2013 Aug 11. — View Citation

Molnar F, Frank CC. Determining the causes of postural hypotension. Can Fam Physician. 2018 Jan;64(1):40. — View Citation

Ronksley PE, Brien SE, Turner BJ, Mukamal KJ, Ghali WA. Association of alcohol consumption with selected cardiovascular disease outcomes: a systematic review and meta-analysis. BMJ. 2011 Feb 22;342:d671. doi: 10.1136/bmj.d671. Review. — View Citation

Strang NM, Claus ED, Ramchandani VA, Graff-Guerrero A, Boileau I, Hendershot CS. Dose-dependent effects of intravenous alcohol administration on cerebral blood flow in young adults. Psychopharmacology (Berl). 2015 Feb;232(4):733-44. doi: 10.1007/s00213-01 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Vessel diameter index (VDI) VDI is calculated using both the vessel area map and the skeletonized vessel map, to yield the averaged vessel caliber. 3 weeks
Primary Vessel area density (VAD) VAD is calculated as a unit-less ratio of the total image area occupied by the vasculature to the total image area in the binary vessel maps. 3 weeks
Primary Flow impairment region (FIR) FIZ: calculated by summing all 'no-flow' pixels up. 3 weeks
Primary Retina-choroid blood flow Blood flow for the entire retinal thickness were determined as a function of the distance from the optic nerve head, where the blood flow was measured at the peaks of the projection profiles. An region of interest outlining the posterior retina with a size of 0.7 to 0.8 mm across the retina-choroid thickness in the parafoveal region was used to obtain the blood flow signal time courses and averaged the values. 3 weeks
Primary Cerebral blood flow (CBF) The frontal lobe was selected as the region of interest (ROI) to measure and average the changes in CBF 3 weeks
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